1. Field of the Invention
The subject invention relates to a pre-packaged medical device including a tray supporting a medical device, such as a blood collection set with an attached tube holder, and to the assembly and positioning of the blood collection set and attached tube holder within the tray. The invention also relates to a method for packaging a medical device such as a blood collection set having an attached tube holder within the tray.
2. Description of Related Art
A blood collection set is used to access a blood vessel of a patient and to draw blood from the patient. The blood collection set typically includes a needle cannula with a proximal end, a sharply pointed distal end, and a lumen extending between the ends. The proximal end of the needle cannula is typically mounted to a plastic hub. The hub is formed with an axial passage that communicates with the lumen through the needle cannula. Flexible tubing of appropriate length is mounted to the end of the hub opposite the needle cannula, and a fitting is mounted to the end of the plastic tubing remote from the needle hub. The fitting may be configured for mating with a container, such as an evacuated blood collection tube or a blood bag, or a holder to secure such container. Thus, the blood collection set may be used to deliver a sample of blood from a patient to a container.
Many blood collection sets include a safety shield that is retained in a proximal position on the needle hub prior to use of the blood collection set. After use, however, the safety shield is moved distally relative to the needle hub to a position where the safety shield surrounds the needle cannula. Some such shielding operations may be carried out manually. Thus, the user may hold the proximal end of the hub and/or the plastic tubing in one hand and move the shield distally with the other hand. The shield often locks with structure on the hub to prevent the shield from sliding completely off the hub and to prevent re-exposure of the needle cannula.
More recent developments in blood collection sets include automatically actuated safety shielding. For example, a spring may be disposed between the needle hub and the safety shield. A latch retains the safety shield in the proximal position on the hub and against the force of the spring. However, a push button actuator releases the latch in response to digital pressure by the user. The spring then propels the shield distally and into a shielding disposition around the needle cannula.
Many medical devices, including blood collection sets, are packaged in sterile blister packages. The typical prior art blister package includes a standard plastic tray for storing the medical device and a plastic cover removably secured across peripheral regions of the standard plastic tray.
Few blister packages provide sufficient compressive structural rigidity and/or protection of the actuator button. Thus, there remains the possibility that the medical device may shift and the actuator button of the blood collection set will be triggered inadvertently by forces exerted on the blister package during storage or shipment, or by forces generated when a user manually grips a blister package. In addition, known blister packages have not been designed to accommodate or nest with other blister packages within the same case to further prevent inadvertent activation of the blood collection set actuator button.
An inadvertent depression of the actuator button could urge the automatic safety shield distally relative to the needle cannula and will lock the shield in a position that prevents further use of the needle cannula. Thus, an unused blood collection set may have to be discarded due to an inadvertent actuation of the safety shielding caused by ordinary gripping of the blister package in which the blood collection set is sealed.
The fitting at the end of the plastic tube opposite the needle hub may include a second needle cannula for extending through the seal of an evacuated blood collection tube during use. Forces on the blister package could deform the blister package sufficiently for the needle to be urged through either the walls of the tray or through the plastic cover of the blister package. A protruding needle cannula would create the risk for an accidental needle stick. Additionally, prior art blood collection sets typically further require a band to maintain the tubing in an orderly coil within the confines of the blister package. Such a band accomplishes the task of controlling the tubing, but adds to the cost and time to complete the packaging of the blood collection set.
Accordingly, a need exists for an improved package and method for storing and transporting medical devices that provides easy and simple assembly of the medical device in the package, adequately restrains and protects the medical device during transport, is easily transported, and is easy for the end user to open to access and remove the device.